NCT03948594

Brief Summary

This study conducted is to assess effect of carbohydrate loading (maltodextrin with whey protein) to gastric volume 2 hours after ingestion via aspiration while doing OGDS (direct visualisation) and patient's wellbeing (hunger, thirst, weakness, tiredness, anxiety) for all patient planned for OGDS. hypothesis H1: There is significant association between carbohydrate loading with residual gastric volume and subject's wellbeing H0: there is no significant association between carbohydrate loading with gastric residual volume and subject's wellbeing

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

April 30, 2019

Last Update Submit

May 15, 2019

Conditions

Gastric Residual Volume

Keywords

resourcegastric residual volumehunger score

Outcome Measures

Primary Outcomes (1)

  • gastric residual volume

    Amount of gastric residual volume (ml) that has been aspirated via OGDS 2 hours after plain water or carbohydrate loading group

    2 hours after plain water or carbohydrate loading

Secondary Outcomes (1)

  • patient's wellbeing

    baseline (before drink) and 120minutes after drinking

Study Arms (2)

plain water

PLACEBO COMPARATOR

subject drink 250cc plain water

Other: plain water

resource

ACTIVE COMPARATOR

subject drink 1 packet resource(237ml)

Dietary Supplement: resource

Interventions

resourceDIETARY_SUPPLEMENT

1 packet resource(237ml), 1.05kcal/ml, 53.6g carbohydrate and 9g protein

resource
plain waterOTHER

250ml plain water

plain water

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient more than 18 years old

You may not qualify if:

  • History of upper gastrointestinal surgery
  • Intestinal obstruction
  • Patient with vomiting
  • Mentally disable or who cannot give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

    PMID: 21236454RESULT

  • Asai T. Editorial II: Who is at increased risk of pulmonary aspiration? Br J Anaesth. 2004 Oct;93(4):497-500. doi: 10.1093/bja/aeh234. No abstract available.

    PMID: 15361474RESULT

  • Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Steele SR, Feldman LS. Clinical practice guideline for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons (ASCRS) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2017 Sep;31(9):3412-3436. doi: 10.1007/s00464-017-5722-7. Epub 2017 Aug 3. No abstract available.

    PMID: 28776285RESULT

  • Dalal KS, Rajwade D, Suchak R. "Nil per oral after midnight": Is it necessary for clear fluids? Indian J Anaesth. 2010 Sep;54(5):445-7. doi: 10.4103/0019-5049.71044.

    PMID: 21189883RESULT

  • Faria MS, de Aguilar-Nascimento JE, Pimenta OS, Alvarenga LC Jr, Dock-Nascimento DB, Slhessarenko N. Preoperative fasting of 2 hours minimizes insulin resistance and organic response to trauma after video-cholecystectomy: a randomized, controlled, clinical trial. World J Surg. 2009 Jun;33(6):1158-64. doi: 10.1007/s00268-009-0010-x.

    PMID: 19363695RESULT

  • Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.

    PMID: 18331374RESULT

  • Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.

    PMID: 11682427RESULT

  • Helminen H, Viitanen H, Sajanti J. Effect of preoperative intravenous carbohydrate loading on preoperative discomfort in elective surgery patients. Eur J Anaesthesiol. 2009 Feb;26(2):123-7. doi: 10.1097/EJA.0b013e328319be16.

    PMID: 19142085RESULT

  • Hofman DL, van Buul VJ, Brouns FJ. Nutrition, Health, and Regulatory Aspects of Digestible Maltodextrins. Crit Rev Food Sci Nutr. 2016 Sep 9;56(12):2091-100. doi: 10.1080/10408398.2014.940415.

    PMID: 25674937RESULT

  • Kaska M, Grosmanova T, Havel E, Hyspler R, Petrova Z, Brtko M, Bares P, Bares D, Schusterova B, Pyszkova L, Tosnerova V, Sluka M. The impact and safety of preoperative oral or intravenous carbohydrate administration versus fasting in colorectal surgery--a randomized controlled trial. Wien Klin Wochenschr. 2010 Jan;122(1-2):23-30. doi: 10.1007/s00508-009-1291-7.

    PMID: 20177856RESULT

  • Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.

    PMID: 21781358RESULT

  • Nason KS. Acute Intraoperative Pulmonary Aspiration. Thorac Surg Clin. 2015 Aug;25(3):301-7. doi: 10.1016/j.thorsurg.2015.04.011.

    PMID: 26210926RESULT

  • Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.

    PMID: 16919107RESULT

  • Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.

    PMID: 8526579RESULT

  • Tran S, Wolever TM, Errett LE, Ahn H, Mazer CD, Keith M. Preoperative carbohydrate loading in patients undergoing coronary artery bypass or spinal surgery. Anesth Analg. 2013 Aug;117(2):305-13. doi: 10.1213/ANE.0b013e318295e8d1. Epub 2013 Jun 11.

    PMID: 23757474RESULT

  • Lua BC, Md Hashim MN, Wong MS, Lee YY, Zakaria AD, Zakaria Z, Wan Zain WZ, Syed Abd Aziz SH, Yahya MM, Wong MP. Efficacy and safety of pre-gastroscopy commercial carbohydrate-rich whey protein beverage vs. plain water: a randomised controlled trial. Sci Rep. 2022 Oct 17;12(1):17355. doi: 10.1038/s41598-022-22363-1.

    PMID: 36253448DERIVED

Related Links

MeSH Terms

Interventions

Health Resources

Intervention Hierarchy (Ancestors)

Health PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Bee Chen Lua, M.D.

    USM surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bee Chen Lua, M.D.

CONTACT

+60127107200beechen0806@outlook.com

Pak Kai Wong, M.Med Surgery

CONTACT

+60143339628michaelpkwong@usm.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Allocation sequence is according computer generated random number list, it was prepared by an investigator with no clinical involvement in the trial. Allocation sequence was concealed from researcher enrolling and assessing participants. Allocation sequence will be sealed in sequentially numbered and opaque envelopes. A manila card will be placed inside envelop to render it impermeable to intense light. To prevent subversion of the allocation sequence, the name and I/C of the participant will be written on a book together with the series number on envelopes. The details in the book will be kept confidentially. After enrolled subject complete all baseline assessment, corresponding envelope will be enclosed by staff (who not involve in study) who prepare the drink. The staff need to ensure that the envelop still sealed when receive it. The staff will prepare the drink into identical container according to the assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects are randomised into 2 group: group A with 250cc plain water and group B with 1 packet resource(237ml)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 14, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 17, 2019

Record last verified: 2019-05